RESEARCH TRIANGLE PARK, NC, June 24, 2021 (GLOBE NEWSWIRE) – Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a specialty pharmaceutical company focused on the development of PEDMARKMT (a unique formulation of sodium thiosulfate) for the prevention of platinum-induced ototoxicity in pediatric patients with localized and non-metastatic solid tumors, today announced an amendment to its existing senior debt facility with Life Bridge Bank’s Sciences Group increasing the size of the facility from $ 18 million to $ 20 million.
The U.S. operating subsidiary of Fennec Pharmaceuticals Inc. has entered into a second amendment to the 2019 loan and guarantee agreement with Bridge Bank. This amendment grants Fennec a loan facility of $ 20 million consisting of three term loans. Term Loan A consists of $ 5.0 million to be funded at closing. Term Loan B consists of $ 7.5 million to be funded upon approval of PEDMARK’s New Drug Application (NDA)MT in the United States, the C term loan consists of $ 7.5 million to be funded in the event of an income generating event in 2022. The interest-only period for the facility can be extended from 18 months to 24 months from the financing of term loan B, provided that term loan C is financed and certain conditions are met. The Company intends to use the proceeds of the loans to provide working capital for business readiness activities prior to NDA approval as well as marketing activities for PEDMARK, if approved.
The United States Food and Drug Administration (FDA) recently agreed to file Fennec’s NDA resubmission for PEDMARK MT and set a target date for action under the Prescription Drug User Fees Act (PDUFA) of November 27, 2021.
“We are pleased to announce this loan amendment to secure up to $ 20 million in credit financing with Bridge Bank, a leading lending institution offering a wide range of services,” said Robert Andrade, Chief Financial Officer by Fennec Pharmaceuticals. âThis credit facility provides a potentially significant extension of our cash flow path, allowing continued support of our business strategy. We believe our senior credit facility will be a valuable financial tool and provide additional flexibility to further unlock opportunities for PEDMARKMT. “
Lauren Cosentino, Vice President of the Life Sciences Group of Bridge Bank, said: âBridge Bank is delighted to continue its partnership with Fennec and to provide flexible debt capital to support its upcoming commercialization activities for PEDMARK â¢, that has the potential to address a significant unmet medical problem. need for prevention of ototoxicity in children receiving cisplatin chemotherapy.
About Fennec Pharmaceuticals
Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development of PEDMARKâ¢ for the prevention of platinum-induced ototoxicity in pediatric patients. Additionally, PEDMARK has received orphan drug designation in the United States for this potential use. Fennec has filed a New Drug Application (NDA) for PEDMARK for the prevention of ototoxicity induced by cisplatin chemotherapy in patients aged 1 month to www.fennecpharma.com
About PEDMARK â¢
Cisplatin and other platinum compounds are essential chemotherapeutic agents for many pediatric malignancies. Unfortunately, platinum-based therapies cause ototoxicity, or hearing loss, which is permanent, irreversible, and particularly harmful to pediatric cancer survivors.
In the United States and Europe, it is estimated that more than 10,000 children each year can receive platinum-based chemotherapy. The incidence of ototoxicity depends on the dose and duration of chemotherapy, and many of these children need hearing aids for life. There is currently no established preventative agent for this hearing loss and only expensive, technically difficult and suboptimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children who suffer from ototoxicity at critical stages of development lack language development and literacy, and older children and adolescents lack socio-emotional development and academic achievement.
PEDMARK has been studied by cooperative groups in two phase 3 clinical studies on survival and reduction of ototoxicity, the clinical oncology group protocol ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol included childhood cancers typically treated with intensive treatment with cisplatin for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, medulloblastoma, and other tumors solid. SIOPEL 6 only recruited hepatoblastoma patients with localized tumors.
The Marketing Authorization Application (MAA) for sodium thiosulfate (trade name PEDMARQSI) is currently being assessed by the European Medicines Agency (EMA). PEDMARK received Breakthrough Therapy and Fast Track designation from the FDA in March 2018.
About Bridge Bank
Bridge Bank, a division of Western Alliance Bank, a member of the FDIC, helps corporate clients achieve their ambitions. Founded in 2001 in Silicon Valley, Bridge Bank offers a better way to bank for small and medium businesses across many industries, as well as for emerging technology companies and the private equity community. Aimed at serving both venture capital and non-venture capital funded businesses, Bridge Bank offers a wide range of financial solutions, including credit facilities for capital, equipment and working capital. , risk debt, cash management, asset lending, SBA and commercial real estate. loans, ESOP financing and a full range of international products and services. Based in San JosÃ©, Bridge Bank has 16 offices in major markets across the country as well as Western Alliance Bank’s powerful portfolio of specialized financial services. Western Alliance Bank is the main subsidiary of Western Alliance Bancorporation, based in Phoenix. One of the nation’s top-performing banking companies, Western Alliance is once again # 1 of the 50 largest US public banks in the new S&P Global Market Intelligence list for 2020 and tops the Forbes list of “Best Banks” of America âof the year. after year. For more information, visit bridgebank.com.
With the exception of historical information described in this press release, all other statements are forward-looking. Words such as “believe”, “anticipate”, “plan”, “expect”, “estimate”, “intend”, “can”, “can”, or the negative of these terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include the Company’s expectations regarding its interactions and communications with the FDA, including the Company’s expectations and objectives regarding the re-submission of NDA for PEDMARK.MT. Obtaining the Fast Track designation and the Breakthrough Therapy designation by the FDA does not guarantee that the FDA will approve the NDA resubmission of PEDMARK. Forward-looking statements are subject to certain risks and uncertainties inherent in the Company’s business that could cause actual results to vary, including the risk that unforeseen factors could cause delays or failure in obtaining approval from PEDMARK. by the FDA, the risks and uncertainties associated with the Company’s reliance on third-party manufacturing, the risks that the Company’s re-submission of NDAs will not adequately address the concerns identified in the CRL previously provided by the FDA, the risk that the re-submission of NDA to the FDA may not be satisfactory, that regulatory and guideline developments may change, the scientific data and / or the manufacturing capabilities may not be sufficient to meet the requirements. regulatory standards or upon receipt of the required regulatory authorizations or approvals, clinical results may not be replicated in the real patient context, unforeseen global instability, including political instability, or the instability of a pandemic or contagious disease outbreak, such as the novel coronavirus (COVID-19), or surrounding the duration and the severity of an epidemic, the protection offered by the Company’s patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company’s products will not be as large as expected, Company products will not be able to penetrate one or more target markets, revenues will not be sufficient to finance further development and clinical studies, the Company may not meet its future capital needs in different countries and municipalities, and other risks detailed from time to time in documents filed by the Company with the Securities and Exchange Commission, including its annual report su r Form 10-K for the fiscal year ended December 31, 2020. Fennec disclaims any obligation to update these forward-looking statements, except as required by law.
For a more detailed discussion of related risk factors, please refer to our public documents available at www.sec.gov and www.sedar.com.
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